INITIAL COMMENTS
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This report is a result of an on-site inspection conducted for the approval to use a narcotic agent, specifically methadone, in the treatment of narcotic addiction. This inspection was conducted on October 3 to 5, 2011, by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Habit OPCO, Inc., Allentown, was found not to be in compliance with the applicable chapters of 4 PA Code and 28 PA Code which pertain to the facility. The following deficiencies were identified during this inspection.
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Plan of Correction
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715.6(d) LICENSURE Physician Staffing
(d) A narcotic treatment program shall provide narcotic treatment physician services at least 1 hour per week onsite for every ten patients
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Observations
Based on the review of administrative documentation, the facility failed to provide at least one hour of physician time a week, on site, for every ten patients.
The findings include:
Physician time sheets and and census reports for the months of April, May, June, July, August and September, 2011, were reviewed on October 5, 2011. There were insufficient onsite physician hours during May and July.
During the week of May 8-14, 2011, the census was 153 patients and 12.5 physician hours were documented as provided to the facility's patients during this time period. The facility was required to provide 15.3 hours of physician services during this time period.
During the week of July 24-30, 2011, the census was 153 patients and 9.5 physician hours were documented as provided to the facility's patients during this time period. The facility was required to provide 15.3 physician hours during this time period.
The findings were reviewed and confirmed with the Facility Director.
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Plan of Correction
The Program Director has instituted a new system for tracking physician coverage. The Program Director has developed a special calendar for the computer, which tracks the weekly census and the number of hours actually provided by the program physician. The Program Director has also met with the Medical Director and Narcotic Treatment Program Physician to address the scheduling of coverage for holidays in advance. The Program Director will provide weekly oversight of the number of physician hours scheduled and provided on an ongoing basis. |
715.8(1)(vi) LICENSURE Psychosocial Staffing
A narcotic treatment program shall comply with the following staffing ratios as established in Chapter 704 (relating to staffing requirements for drug and alcohol treatment activities):
(vi) Outpatients. The counseling caseload for one FTE counselor in an outpatient narcotic treatment program may not exceed 35 active patients.
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Observations
Based on the review of administrative documentation, the facility failed to maintain counselor caseloads to no more than 35 to 1.
The findings include:
Administrative documentation that included counselor caseloads from June 30, 2011, to October 5, 2011, was reviewed and discussed with staff on October 5, 2011. Counselor caseload documentation of June 30, 2011, indicated employee # 1 had a caseload of 36:1.
Additionally, upon review of the current census and caseload counts, 8 patients were unaccounted for. Employee # 1, no longer working at the facility, was listed as having a caseload.
The findings were reviewed and confirmed with the Facility Director and Clinical Supervisor.
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Plan of Correction
The Clinical Director will review the counselor caseloads each Friday to assess compliance with the regulation. All patients who do not have a counselor and cannot be assigned to current counselor due to the 35:1 regulation will be assigned to a member of the management team who meets the criteria as a counselor. This shall include the Program Director and, secondarily, the Clinical Director, until additional clinical staff is hired to handle the additional caseloads. Each of these patients will be seen for individual counseling by the assigned counselor and will receive group treatment in accordance with their treatment plan and treatment needs.
The PRogram Director is responsible for ensuring that the corrective action is implemented. It was completed by November 3, 2011. |
715.12(1-5) LICENSURE Informed patient consent
A narcotic treatment program shall obtain an informed, voluntary, written consent before an agent may be administered to the patient for either maintenance or detoxification treatment. The following shall appear on the patient consent form:
(1) That methadone and LAAM are narcotic drugs which can be harmful if taken without medical supervision.
(2) That methadone and LAAM are addictive medications and may, like other drugs used in medical practices, produce adverse results.
(3) That alternative methods of treatment exist.
(4) That the possible risks and complications of treatment have been explained to the patient.
(5) That methadone is transmitted to the unborn child and will cause physical dependence.
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Observations
Based on a review of patient records, the facility failed to obtain an informed, voluntary, written consent prior to the administration of a narcotic agent for maintenance treatment in two of twenty-three patient records.
The findings include:
Twenty-three patient records were reviewed on October 3 - 5, 2011, all patient records required the completion of an informed, voluntary written consent prior to the administration of a narcotic agent. The facility failed to document the completion of an informed, voluntary, written consent prior to the administration of a narcotic agent in patient record # 8 and # 10.
Patient # 8 was admitted into treatment on April 18, 2011, as a transfer. The patient received their initial dose of methadone on April 18, 2011. There was no documentation of an informed consent prior to the patient's induction into methadone treatment. Patient # 10 was readmitted on October 3, 2011. The patient received their initial dose of methadone on October 3, 2011. There was no documentation of an informed consent prior to the patient's induction into methadone treatment.
The findings were reviewed and confirmed with the Facility director.
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Plan of Correction
Following the exit interview, the consent form for Patient # 8 was located by the Nurse Manager. The Nurse Manager, who has responsibility for ensuring that the voluntary consent forms are properly completed and filed, has developed a system for double-checking the intake paperwork, including the voluntary consent forms. The forms are now provided to the physician on the date the patient is scheduled for the admission physical. Immediately following the completion of the admission physical, the physician returns the forms to the Nurse Manager or her designee from the nursing staff, who reviews the entire file for completeness before turning it in to the clerical staff. The patient is not medicated until this process is completed.
The corrective action was implemented by October 31, 2011. |
715.15(b) LICENSURE Medication dosage
(b) The narcotic treatment physician shall determine the proper dosage level for a patient, except as otherwise provided in this section. If the narcotic treatment physician determining the initial dose is not the narcotic treatment physician who conducted the patient examination, the narcotic treatment physician shall consult with the narcotic treatment physician who performed the examination before determining the patient 's initial dose and schedule.
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Observations
Based on the review of patient records, the facility failed to demonstrate the physician made a determination of the patient's dose during the induction phase of treatment in one of twenty-three patient records.
The findings include:
Twenty-three patient records were reviewed on October 3 - 5, 2011. Patient # 19 was admitted into treatment on September 12, 2011, and received an initial dose of 25 mg on the same date. A review of the patient record revealed an order on September 19, 2011, for an increase to "35 mg today and to 45 mg in 3 days." An order on September 27, 2011, documented an order to increase "10 mg to 55 mg today then on September 29" increase "10 mg to 65 mg and maintain."
The findings were reviewed and confirmed with the Facility Director, lead Counselor and Director of Nursing.
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Plan of Correction
On October 21, 2011, the policies regarding induction were revised for all Habit OPCO programs, including Allentown, and these policy changes were reviewed and provided to all program physicians. The changes included the expectation that all patients receive "individualized care and assessment," which does include any dose adjustments.
The Medical Director and the Nurse Manager will review all orders for all patients during the induction phase of treatment for the next quarter to ensure that the revised policy is being followed. |
715.17(c)(1)(i-vi)) LICENSURE Medication control
(c) A narcotic treatment program shall develop and implement written policies and procedures regarding the medications used by patients which shall include, at a minimum:
(1) Administration of medication.
(i) A narcotic treatment physician shall determine the patient 's initial and subsequent dose and schedule. The physician shall communicate the initial and subsequent dose and schedule to the person responsible for the administration of medication. Each medication order and dosage change shall be written and signed by the narcotic treatment physician.
(ii) An agent shall be administered or dispensed only by a practitioner licensed under the appropriate Federal and State laws to dispense agents to patients.
(iii) Only authorized staff and patients who are receiving medication shall be permitted in the dispensing area.
(iv) There shall be only one patient permitted at a dispensing station at any given time.
(v) Each patient shall be observed when ingesting the agent.
(vi) Administering and dispensing shall be conducted in a manner that protects the patient from disruption or annoyance from other individuals.
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Observations
Based on direct observation of the medication area, the facility failed to follow their policy and procedures of only authorized patients receiving medication permitted in the dispensing area.
The findings include:
During direct observation of the medication area on October 5, 2011, at about 10 a.m., a staff member with patients went through the dosing area while a patient was being dosed at the medication window.
The findings were reviewed with the Facility Director, Lead Counselor and Nurse Manager. The Nurse Manager confirmed the incident.
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Plan of Correction
All staff members have been instructed that no unauthorized persons are permitted in the dosing area during dosing hours. Patients are now being walked through the dosing area only when there is no other patient at the dosing window. If another patient is at the dosing window, staff members are walking the patients in and out the front door, going around the dosing area on the outside of the building. Signs to that effect are in place. The Security Associate is charged with ensuring that this policy is followed. The Program Director and Administrative Assistant are also charged with ensuring the policy is followed in the absence of the Security Associate.
This corrective action was completed by October 31, 2011. |
717.18(a)(2) LICENSURE Rehabilitative services
(a) A narcotic treatment program shall provide, either onsite or through referral agreements, a full range of rehabilitative services. Rehabilitative services shall include:
(2) Employment services.
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Observations
Based on a review of the Project's policies and procedures, the facility failed to document a referral agreement for rehabilitative services including employment.
The findings include:
During an onsite review of the Project's policy and procedures on October 3 - 5, 2011, the Licensing Specialist reviewed the referral agreements for rehabilitative services. The documented referral agreements did not include employment services.
The findings were reviewed and confirmed with the Facility Director.
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Plan of Correction
On October 14, 2011, the Program Director completed a referral agreement with Nehemiah House, which provides employment services. Additionally, referral agreements are pending with the Office of Vocational Rehabilitation and CareerLink.
The Program Director has developed a tickler file for tracking which referral agreements are current and which are due to be updated. This file is consulted by the Program Director at least once per month, and referral agreements will be obtained or renewed prior to the expiration of the previous agreement. |
715.19(1) LICENSURE Psychotherapy services
A narcotic treatment program shall provide individualized psychotherapy services and shall meet the following requirements:
(1) A narcotic treatment program shall provide each patient an average of 2.5 hours of psychotherapy per month during the patient 's first 2 years, 1 hour of which shall be individual psychotherapy. Additional psychotherapy shall be provided as dictated by ongoing assessment of the patient.
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Observations
Based on a review of patient records, the facility failed to provide each patient an average of 2.5 hours of psychotherapy per month during the patient's first 2 years of treatment in seven of fourteen records.
The findings include:
During an onsite record review on October 3 - 5, 2011, the Licensing Specialists reviewed fourteen records regarding psychotherapy hours. Seven records failed to document an average of 2.5 hours of psychotherapy per month, specifically records # 6, 10, 13, 15, 17, 18 and 19. Four of the records were from employee # 1.
In record # 6, the patient was admitted on September 14, 2011, and had received no psychotherapy services as of the record review.
In record # 10, the patient was admitted on July 13, 2011. The patient received 1 hour of psychotherapy in July 2011, 3.5 hours in August 2011, and 1 hour in September 2011.
In record # 13, the patient was admitted on June 22, 2011. The patient received 3.0 hours of psychotherapy in July 2011, 2.5 hours in August 2011, and 1.5 hours in September 2011.
In record # 15, the patient was admitted on April 15, 2011. The patient received 2.0 hours of psychotherapy in June 2011, 0.5 hours in July 2011, 2.0 hours in August 2011, and 1.5 hours in September 2011.
In record # 17, the patient was admitted on February 25, 2011. The patient received 3.0 hours of psychotherapy in July 2011, 2.5 hours in August 2011, and 1.5 hours in September 2011.
In record # 18, the patient was admitted on March 25, 2011. The patient received 2.0 hours of psychotherapy in July 2011, 1.0 hours in August 2011, and no hours as the patient was hospitalized in September 2011.
Lastly, in record # 19, the patient was admitted on September 9, 2011. The patient received 0.5 hours of psychotherapy in September 2011.
The findings were reviewed and confirmed with the Facility Director and Clinical Supervisor.
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Plan of Correction
At the general staff meeting on October 20, 2011, the regulations regarding psychotherapy services were reviewed and explained in detail.
The Clinical Director and Lead Counselor will review each counselor's compliance with providing the required counseling at the individual supervision during the second and third week of each month. This will allow them to assess compliance and to ensure that there is adequate time each month to provide the required number of counseling hours. The Clinical Director and Lead Counselor will provide a verbal report to the Program Director during the last week of each month regarding compliance with this regulation for three months. |